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Our Service

Genalyte delivers rapid, actionable results to physicians through decentralized laboratory testing, backed by CLIA compliant oversight and monitoring. Our EUA authorized, best in class serology test for the detection of antibodies to SARS-CoV-2 and other respiratory related viruses is performed in 20 minutes with a deployed on-site laboratory. All results are run through CloudLab, our proprietary cloud-based quality oversight platform.

 

Genalyte Services

  • Rapidly deployed on-site laboratory
  • CloudLab platform for remote quality oversight and monitoring
  • Serology test results in 20 minutes
  • Results interpretation

SARS-CoV-2 Multi-Antigen Panel

SARS-CoV-2

  • Anti-Nucleocapsid IgG and IgM
  • Anti-Spike S1 RBD IgG and IgM
  • Anti-Spike S1S2 IgG and IgM
  • Anti-Spike S2 IgG and IgM
  • Anti-Spike S1 IgG and IgM

Benign Coronavirus

  • OC43 Spike
  • HKU1 Spike
  • NL63 Nucleoprotein
  • 229E Spike

SARS-CoV

  • Anti-Nucleocapsid IgG and IgM

MERS

  • Anti-S1  IgG and IgM

Influenza

  • Anti-H1 IgG and IgM
  • Anti-H3  IgG and IgM

 

Deployments

  • Government testing centers
  • Health systems
  • University research institutes
  • Physician offices
  • Long term care facilities
  • Urgent care centers
  • Quarantine/hospital overflow facilities

 

This test has not been FDA cleared or approved; This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the presence of antibodies against SARSCoV-2,  not for any other viruses or pathogens;  and This test is only authorized
for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in  vitro diagnostics for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360